Recruiting

MINDGAPS

Sponsor:

University of Montana

Code:

NCT05986279

Conditions

Vestibular Hypofunction

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Rehab

Study Details

Brief summary:

The purpose of this study is twofold: 1) Develop norms for measures of inner ear function and psychological health, and 2) Examine the feasibility of using the MINDGAPS system (a remote monitoring system) to track progress during physical therapy or rehabilitation for inner ear problems following a concussion or mild Traumatic Brain Injury.

Conditions

Vestibular Hypofunction

Study ID

NCT05986279

Start date

Aug 30, 2023

Status verified date

Dec, 2024

Completion date

Sep 29, 2027

Anticipated

Primary completion date

Sep 29, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Veteran or Active Duty Military Service Member
  • Ability to stand independently
  • Legally autonomous and able to self-consent

Exclusion Criteria:

  • Acute head injury (within the previous 2 months)
  • History of moderate or severe head injury (i.e., loss of consciousness greater than 30 minutes or post-traumatic amnesia greater than 1 day)
  • Current diagnosis of spine disorders in the neck
  • Diagnosis of problems with the arteries in your neck
  • Blindness
  • If you have been diagnosed with abnormal eye movements (also called "ocular motor palsy")
  • If you have previously had a stroke or been diagnosed with a neurodegenerative disorder ( e.g., Parkinson's Disease, Multiple Sclerosis)
  • If you have been previously diagnosed primary vestibular dysfunction ( e.g., congenital peripheral vestibular syndrome)
  • If you have previously been diagnosed with a brain tumor
  • If you are currently receiving physical therapy care for balance or dizziness problems

Study Design

Enrollment

500 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Rehab

6 weeks of vestibular physical therapy guided by the use of the MINDGAPS decision support system

no intervention: Observational

Normative data development of performance on vestibular measures following mTBI

Interventions

Rehab

6 weeks of vestibular rehabilitation guided by the MINDGAPS decision support system

Primary outcome measure

  • Computerized Dynamic Visual Acuity (cDVA) [ Time Frame: through study completion, an average of 12 weeks ]

Central Contacts and Locations

Central contacts

Brian Loyd, PhD

406-243-4015Brian.loyd@umontana.edu

Andy Kittelson, PhD

406-243-4015Andy.kittelson@umontana.edu

Locations

Naval Medical Center San Diego

Recruiting

San Diego, California, United States, 92134

Contacts

Trevor Kingsbury

619-532-7136trevor.d.kingsbury.civ@health.mil

University of Montana

Recruiting

Missoula, Montana, United States, 59812

Contacts

Brian Loyd, PhD

406-243-4015brian.loyd@umontana.edu

Andy Kittelson, PhD

406-243-4015andy.kittelson@umontana.edu

More Information

Sponsor

University of Montana

Last update posted

Dec 6, 2024

Last verified

Dec, 2024

Keywords

  • Rehabilitation
  • mild traumatic brain injury
  • dynamic visual acuity
  • gaze stability
  • postural stability
  • dizziness
  • psychological health

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Montana on 2024-12-06.